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11574en
- Contract
- English
- Mid-Senior level
- Digital & Technology
- Basel
- Healthcare & Life Sciences
Skills
QA, Pharma, Validation, GMP, change control, CAPA management, SAP, HP ALM, manufacturing, compliance
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This vacancy has now expired
For a multinational and well established healthcare organization, Swisslinx are looking for a Quality Assurance Manager, based in Basel, Switzerland. You will be responsible for performing tasks around Computer Systems Validation, Risk Management, Change Control, and CAPA Management whilst working alongside other member of your team.
This is an exciting opportunity for anyone looking to expand their expertise within the life sciences industry.
Tasks & Responsibilities:
- Performing quality assurance tasks (eg. validation of global computerized systems according to GMP inventory)
- Distributing and coordinating quality assurance tasks among the entire organization, and within all departments
- Advising local quality departments
- Provide templates, support in creating of CSV documentation and review and approve of SOP’s, according to the GMP inventory, to assure compliance of systems.
- Support quality assurance tasks, increasing reviewing and approving the validation lifecycle documents/ review and approving of change requests and owning discrepancies.
Background & Experience
- 8+ years of relevant experience in the life sciences sector
- Sound knowledge of cGMP’s or equivalent regulations
- Demonstrated expertise with computer system validation and risk management, change control and discrepancy/CAPA management
- Knowledge of manufacturing and compliance
- Can work in validated or controlled environments
- Proven experience maintaining full compliance to regulations and standards, whilst proposing pragmatic quality approaches
- Proven experience working with SAP / ERP / Serialization Systems
- Previous experience working with HP ALM
- Pays close attention to detail
- Strives for excellence
- A team-player, good communicator, and work with a positive attitude
- Can Multi-task, ability to focus on various tasks at the same time
- Fluent written and verbal communication in the English language
Are you an experienced Quality Assurance Manager looking to work in a hands-on and fast-paced environment? Then please apply online, we look forward to receiving your application!
This is an exciting opportunity for anyone looking to expand their expertise within the life sciences industry.
Tasks & Responsibilities:
- Performing quality assurance tasks (eg. validation of global computerized systems according to GMP inventory)
- Distributing and coordinating quality assurance tasks among the entire organization, and within all departments
- Advising local quality departments
- Provide templates, support in creating of CSV documentation and review and approve of SOP’s, according to the GMP inventory, to assure compliance of systems.
- Support quality assurance tasks, increasing reviewing and approving the validation lifecycle documents/ review and approving of change requests and owning discrepancies.
Background & Experience
- 8+ years of relevant experience in the life sciences sector
- Sound knowledge of cGMP’s or equivalent regulations
- Demonstrated expertise with computer system validation and risk management, change control and discrepancy/CAPA management
- Knowledge of manufacturing and compliance
- Can work in validated or controlled environments
- Proven experience maintaining full compliance to regulations and standards, whilst proposing pragmatic quality approaches
- Proven experience working with SAP / ERP / Serialization Systems
- Previous experience working with HP ALM
- Pays close attention to detail
- Strives for excellence
- A team-player, good communicator, and work with a positive attitude
- Can Multi-task, ability to focus on various tasks at the same time
- Fluent written and verbal communication in the English language
Are you an experienced Quality Assurance Manager looking to work in a hands-on and fast-paced environment? Then please apply online, we look forward to receiving your application!
